BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

    MDR report key: 2901401 · Received January 2, 2013

    Report

    Report Number
    9710014-2012-00497
    Event Type
    Malfunction
    Date Received
    January 2, 2013
    Report Date
    December 28, 2012
    Manufacturer
    MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH
    Product Code
    MCM
    PMA / PMN Number
    P000025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN EXPLANTED. IF IT SHOULD BE EXPLANTED, IT IS TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. WHEN AVAILABLE, A DEVICE FAILURE ANALYSIS WILL BE SUBMITTED AS A FOLLOW REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED, THAT THE PT, IMPLANTED IN 2004, CAN NO LONGER HEAR WITH HER CI. TO DATE, IT IS NOT CONFIRMED WHETHER THE PT HAD AN IMPACT OR ACCIDENT. RE-IMPLANTATION SURGERY IS CONSIDERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    609 MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM C40+ STANDARD MCM MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR